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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM

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AV-TEMECULA-CT XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Catalog Number 1011710-28
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Dyspnea (1816); Headache (1880); Dizziness (2194); Diaphoresis (2452)
Event Date 12/01/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. There was no reported device malfunction and the product was not returned. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. The reported patient effect of angina is listed in the xience prime everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures. A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined and there is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that on (b)(6) 2014 the 3. 5x28 mm xience prime stent was implanted in the distal circumflex coronary artery and the 4. 0x23 mm xience prime stent was implanted in the proximal cx artery. In (b)(6) 2015, the patient had intermittent chest tightness, shortness of breath, sweating, headache, and dizziness. The patient was re-admitted to the hospital on (b)(6) 2016. This was classified as unstable angina. Medication was given intravenously and the condition resolved on (b)(6) 2016. The patient was discharged. No additional information was provided.
 
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Brand NameXIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Type of DeviceDRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
CLONMEL, IRELAND REG# 9616693
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key6745441
MDR Text Key81112496
Report Number2024168-2017-06224
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 07/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/26/2016
Device Catalogue Number1011710-28
Device Lot Number3021341
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/26/2017 Patient Sequence Number: 1
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